SOURCES SOUGHT
66 -- Flow Cytometric Cell Sorter System
- Notice Date
- 4/29/2014
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1130560
- Archive Date
- 5/22/2014
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research's (CBER) requirement for one (1) Flow Cytometric Cell Sorter System to include inside delivery, installation, standard installation/performance testing, training, warranty and up to four (4) 1-year option periods for post-warranty maintenance. This is a sources sought to determine the availability and capability of small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer. The associated North American Industry Classification System (NAICS) Code is‐ 334516 ‐ Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. REQUIREMENTS: Part I: General Information A. Introduction The CBER has a requirement for one (1) Flow Cytometric Cell Sorter to analyze cells for various functional and phenotypic attributes. Furthermore, CBER requires a Flow Cytometric Cell Sorter with the ability to physically separate cells, either for culture or other purposes. The functional and phenotypic attributes stated above can range from simple size differences to as many as 20 unique features for analysis and sorting. The instrument required shall have as many detectors and independent excitation sources to achieve the range of the necessary analytical goals, and provide laser expandability. The instrument shall provide an optical design to maximize sensitivity for fluorescence detection. B. Background CBER presently has four (4) Becton Dickinson (BD) FACS-type instruments in operation: BD Fluorescence-Activated Cell Sorting (FACS) Aria IIu, Serial No. P69500102; BD LSR Fortessa, Serial No. H64717700037; BD LSRII, Serial No. H1110; and BD LSRFortessa X-20, Serial No. H656385001. Another Cell Sorter, BD FACSAria III Fusion - Serial Number 5000304530, is scheduled to be installed soon into the new FDA White Oak facility currently in construction. While none of these systems physically interface, all are operated with BD FACSDiva software and operate similarly regarding lasers/optics, fluidics, etc. In order to avoid / minimize scientific and technical disruption, the system shall provide a solution for compatibility with the current technology in use. C. Scope The Contractor shall provide one (1) completely configured, high content, Flow Cytometric Cell Sorter to optimally achieve the work described above to include, but not be limited to all necessary accessories, software, hardware, drivers, libraries, equipment, supplies, adapters, cables, workstations/monitors, filters, lasers, plates, slides, tubes, as a safe, seamless, turn-key solution. The Contractor shall be responsible for inside delivery, installation, standard installation/performance testing, training, warranty and up to four (4) 1-year option periods for post-warranty maintenance. This system will provide analytical and sorting flow cytometry for a wide range of applications and CBER core clients. In order to expand access and ease scheduling restrictions, the CBER core is responsible for training core clients to operate the systems. For this purpose, ease-of-use features are important. The system shall operate optimally without requiring daily optical alignment. Additionally, daily performance evaluations shall be automated, and the daily performance evaluation shall provide updates to optimized instrument settings (maximizing signal resolution and sensitivity). These optimized settings shall be included automatically as part of the experiment protocol setup. These protocols shall be savable, and updated automatically according to the automated performance evaluation process. Part II: Work Requirements A. Technical Requirements The system shall: • Have a minimum of five (5) lasers. • Provide a cuvette flow cell, gel coupled to the fluorescence objective lens. • Shall automatically rinse the inside and outside of the sample sipper after each sample. • Be capable to perform to the following list of optical filter options to include Detector optics, required laser lines, and the likely fluorochromes to be used: Laser LongPass Filter BandPass Filter Possible Fluorochromes UV (355nm) -- 379/28 Brilliant Violet (BV) UV 685LP 730/45 BUV 340 Blue (488nm) 505LP 525/50 FITC 670LP 710/50 PerCP-Cy5.5 Violet (405nm) -- 450/50 BV421 505LP 525/50 BV 510 595LP 610/20 BV 605 635LP 670/30 BV 650 695LP 710/50 BV 711 750LP 780/60 BV 786 YellowGreen (561nm) 550LP 575/26 PE 600LP 610/20 PE-Texas Red 635LP 670/30 PE-Cy5 685LP 710/50 PE-Cy5.5 740LP 780/60 PE-Cy7 Red (640nm) -- 670/30 APC 690LP 730/45 Alexa 700 750LP 780/60 APC-Cy7 B. Installation, Testing and Training Requirements: The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include inside delivery. The equipment shall be tested once installed to verify all aspects of the system are operating within parameters of the required specifications. The Contractor shall demonstrate upon completion of installation and testing that the item meets all specifications. All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system. Upon acceptance of the system, training shall be provided to a minimum of two (2) attendees/users by the Contractor's trained and certified personnel. C. Service Requirements: At a minimum, the Contractor shall provide the following services during the option periods for post-warranty periods: - Two (2) preventative maintenance visits per contract year inclusive of all labor, travel, and parts, components, subassemblies, etc. necessary to provide the service. - Unlimited on-site corrective/remedial maintenance/repairs to be scheduled at the time of service request within five (5) calendar days from service call. On-site repair service shall be inclusive of all labor, travel, certified replacement parts, components, subassemblies, etc. needed to return the system to operational capacity. - Unlimited technical support and trouble-shooting assistance, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Eastern Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) - Formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc. - Unlimited software and firmware updates. - The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket by email identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Contracting Officer's Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Part III: Supporting Information A. Place of Performance Physical location for inside delivery, installation, testing, training and maintenance of the system at: U.S. Food and Drug Administration Bldg 52, Room 1151 (White Oak Standard Flow Lab) 10903 New Hampshire Avenue, Silver Spring, MD 20993 Delivery, installation, testing, training and maintenance shall be coordinated with the COR (to be provided with contract). B. Period of Performance Delivery of Flow Cytometer System, to include inside delivery, installation, testing, IQ/OQ/PQ, and training expected within ninety (90) calendar days of award with up to four (4) 1-year post-warranty maintenance option periods. Responses to this sources sought shall unequivocally demonstrate that respondent is regularly engaged in the manufacture and/or sale of same or substantially similar items. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; [Provide this same information again for the manufacturer/producer if responding to provide a product manufactured by another firm.] • Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items, which are or have been used with same or similar equipment for same or similar purposes, to include date of sale, description (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if respondent is not the manufacturer/producer; • Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the items the responding firm is regularly engaged in manufacturing and/or selling; • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; • If a large business, identify any existing subcontracting opportunities for small business concerns; • Although this is not a request for quote, informational pricing is encouraged; • The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before May 7, 2014 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT‐320, Jefferson, AR 72079‐9502, or email crystal.mccoskey@fda.hhs.gov. Reference #1130560 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a combined synopsis/solicitation (No. 1130560) may be published via FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1130560/listing.html)
- Place of Performance
- Address: U.S. Food and Drug Administration, Bldg 52, Room 1151 (White Oak Standard Flow Lab), 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03351481-W 20140501/140429234656-b6e98d723826b78b3a19f0b6240ec923 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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